M D Chen1, P J Paley, R A Potish, L B Twiggs. 1. Department of Obstetrics and Gynecology, University of Minnesota, Minneapolis, Minnesota 55455, USA.
Abstract
OBJECTIVE: The aim of this study was to determine tolerable doses and potential toxicities of taxol, administered weekly, with concomitant cisplatin and radiation therapy in advanced cervical cancer. METHODS: Patients with cervical cancer, either with evidence of distant metastatic disease at presentation or otherwise at high risk for recurrent disease, were eligible for this phase I study. Taxol was administered weekly as a 3-hr intravenous infusion in addition to the prescribed radiation therapy. The starting dose was 10 mg/m2/week and escalated at 10 mg/m2/week increments if tolerated by successive cohorts of three new patients. Cisplatin was given every 3 weeks at 50 mg/m2. Chemotherapy was continued until radiation was completed. For each patient quality of life was assessed weekly during therapy. RESULTS: Sixteen patients, undergoing a total of 102 cycles, have been enrolled. Dose escalation of taxol from 10 mg/m2/week to 50 mg/m2/week was well tolerated, with no significant change in quality of life during therapy. Two radiation fractions (0.5%) were delayed due to toxicity from this chemotherapy regimen. Of 102 cycles, 6 resulted in grade 2 and 1 in grade 3 neutropenia, and no patient developed >grade 2 anemia or thrombocytopenia. Three patients developed GI-related toxicities and 1 patient presented with urosepsis during treatment. There was a 93% response rate to this regimen, with 10 patients (63%) presently having no evidence of disease. CONCLUSIONS: This study has demonstrated that up to 50 mg/m2/week of taxol is well tolerated in patients undergoing radiation therapy for advanced cervical cancer. A phase II trial will assist in determining the efficacy of taxol as a radiation sensitizer in these patients. Copyright 1997 Academic Press.
OBJECTIVE: The aim of this study was to determine tolerable doses and potential toxicities of taxol, administered weekly, with concomitant cisplatin and radiation therapy in advanced cervical cancer. METHODS:Patients with cervical cancer, either with evidence of distant metastatic disease at presentation or otherwise at high risk for recurrent disease, were eligible for this phase I study. Taxol was administered weekly as a 3-hr intravenous infusion in addition to the prescribed radiation therapy. The starting dose was 10 mg/m2/week and escalated at 10 mg/m2/week increments if tolerated by successive cohorts of three new patients. Cisplatin was given every 3 weeks at 50 mg/m2. Chemotherapy was continued until radiation was completed. For each patient quality of life was assessed weekly during therapy. RESULTS: Sixteen patients, undergoing a total of 102 cycles, have been enrolled. Dose escalation of taxol from 10 mg/m2/week to 50 mg/m2/week was well tolerated, with no significant change in quality of life during therapy. Two radiation fractions (0.5%) were delayed due to toxicity from this chemotherapy regimen. Of 102 cycles, 6 resulted in grade 2 and 1 in grade 3 neutropenia, and no patient developed >grade 2 anemia or thrombocytopenia. Three patients developed GI-related toxicities and 1 patient presented with urosepsis during treatment. There was a 93% response rate to this regimen, with 10 patients (63%) presently having no evidence of disease. CONCLUSIONS: This study has demonstrated that up to 50 mg/m2/week of taxol is well tolerated in patients undergoing radiation therapy for advanced cervical cancer. A phase II trial will assist in determining the efficacy of taxol as a radiation sensitizer in these patients. Copyright 1997 Academic Press.
Authors: Anuja Jhingran; Lois M Ramondetta; Diane C Bodurka; Brian M Slomovitz; Jubilee Brown; Lawrence B Levy; Michael E Garcia; Patricia J Eifel; Karen H Lu; Thomas W Burke Journal: Gynecol Oncol Date: 2013-02-04 Impact factor: 5.482